Regulatory Affairs Public Trust

Nancy Smyth Templeton, PhD

Email address: ***************@*****.***

Address: **** ********* **** ****, ********, MD 20817 (Washington DC Metro Area)

Cell Phone Number: 832-***-****

** ***** ****harmaceutical R&D Experience

32 years Project & Program Management Experience

24 years Regulatory Affairs & Strategies Experience

24 years Senior Executive Pharmaceutical Experience

5 years Large Pharma Operations Management Experience

Security Clearances:

SECRET (DoD)

Public Trust (DoD)

Public Trust (DHHS)

Bio:

After completing her MS in Cell Biology and Genetics, PhD in Molecular Biology and Biochemistry, and post-doctoral training at the NCI and NHLBI, National Institutes of Health; Dr. Templeton spent 11 years as a Faculty Member at the Baylor College of Medicine, Houston TX. There she launched and supervised a research laboratory, non-viral core facility, GMP-like manufacturing facility, and a Baylor start-up biotechnology company that further developed her novel nanotechnology delivery system used to treat acquired disorders and inherited diseases. She also taught graduate and medical students (awarded 2 Fulbright & Jaworski Faculty Excellence Awards), mentored MS and PhD students (including Thesis Research Advisor) and provided extensive support for FDA submissions and clinical trials including GMP manufacturing. Dr. Templeton also holds and has held positions as a Chief Executive Officer (CEO) and Chief Scientific Officer (CSO), Director and Senior Scientist in small biotechnology companies including ParaGen LLC, Gradalis Inc, and MegaBios LLC, respectively. She is also an experienced entrepreneur having launched biotechnology companies GeneExcel LLC and Optimal Expressions LLC, serving as a CEO and CSO for both, and brought the former company through to acquisition. She has also served on numerous Review Panels, Professional Committees, Advisory Boards, and Ad Hoc reviews for several scientific journals. Dr. Templeton is also an inventor on numerous issued patents and is the editor for 6 CRC published scientific books. She has served as a consultant for several large and small pharmaceutical companies. She has 63 publications in peer-reviewed journals and presented approximately 150 invited seminars both nationally and internationally. She successfully completed numerous advanced DoD and NIH training courses relevant to functioning in her contract/consultant positions as a Senior Regulatory Affairs Manager supporting ONE-RAQA and the JPEO-CBRND and DTRA JSTO-CB at Ft. Detrick with the Logistics Management Institute (LMI) and as a Regulatory/Quality Specialist for the Office of Sponsor and Regulatory Oversight (OSRO), National Cancer Institute, NIH with the Astrix Technology Group. Dr. Templeton served as a Senior Project Manager and an Operations Manager for Takeda Pharmaceuticals Inc. supported by eTeam Inc. and Oxford Global Resources. She completed contracting for Tata Consultancy Services (TCS) as a Senior Business Consultant, and is currently an Independent Contractor/Consultant. Dr. Templeton has held a SECRET Security Clearance and Public Trust Clearances for the DoD and for the DHHS.

Education:

PhD, Molecular Biology and Biochemistry, Wesleyan University, Middletown CT

MS, Genetics and Cell Biology, University of Connecticut, Storrs CT

BS, Education & Sciences, The City College of the City University of NY (CCNY), NYC NY

Training:

Post-doctoral Training:

Biotechnology Fellow, Laboratory of Pathology, NCI NIH, Bethesda MD

Senior Staff Fellow, Molecular Hematology Branch, NHLBI NIH, Bethesda MD

DoD Administrative Training:

Completed DAU Core Certification Standards for Science and Technology Manager Level 1, and all online training for Levels 2 and 3 Core Certification Standards

Completed DAU Core Certification Standards for Production, Quality and Manufacturing Level 1, and all online training for Levels 2 and 3 Core Certification Standards

Completed DAU Core Certification Standards for Requirements Management Levels A and B, and all online training for Levels C and D Core Certification Standards

Completed DAU Core Certification Standards for Engineering Level 1, and all online training for Levels 2 and 3 Core Certification Standards

Completed DAU Core Certification Standards for Program Management Level 1,

Intermediate Medical Acquisition Course 2.0 (IMAC 2.0; equivalent to DAU ACQ 203),

Defense Acquisition University (DAU) Orientation,

DAU ACQ 202 – Intermediate Systems Acquisitions Course,

DAU ACQ 101 – Fundamentals of Systems Acquisition Management Training,

DAU CLM 014 – Team Management and Leadership Training,

DAU STM 101 – Introduction to Science and Technology Management,

DAU ENG 101 – Fundamentals of Systems Engineering,

DAU ENG 201 – Applied Systems Engineering in Defense Acquisition, Part 1,

DAU CLE 068 – Intellectual Property and Data Rights,

DAU CLM 017 – Risk Management,

DAU CLE 021 – Technology Readiness Assessments,

DAU CLE 082 – Prototyping and Experimentation,

DAU CLE 069 – Technology Transfer,

DAU CLE 003 – Technical Reviews,

DAU PQM 101 – Production, Quality and Manufacturing Fundamentals,

DAU PQM 201A – Intermediate Production, Quality and Manufacturing, Part A,

DAU LOG 204 – Configuration Management,

DAU LOG 104 – Reliability, Availability, and Maintainability (RAM),

DAU CLR 101 – Introduction to the Joint Capabilities Integration & Development System,

DAU RQM 110 – Core Concepts for Requirements Management,

DAU CLL 008 – Designing for Supportability in DoD Systems,

DAU CLE 019 – Modular Open Systems Approach (MOSA),

DAU CLV 016 – Introduction to Earned Value Management,

DAU CLB 007 – Cost Analysis,

DAU EVM 101 – Fundamentals of Earned Value Management,

Advanced Other Transaction Authority (OTA) Training,

Agreement Officer Representative (AOR) Training,

Level I Antiterrorism Awareness Training,

Army OPSEC (Operations Security) Level I Training,

Identifying and Safeguarding Personally Identifiable Information (PII) Training,

Initial Security Orientation,

Introduction to the Knowledge Center Training,

Share Point – Basic User/New Features Training

NCI Regulatory Administrative Training:

Biomedical 101, CITI Program for NIH

Good Clinical Practice (US FDA focus), CITI Program for NIH

Vulnerable Subjects – Research Involving Children, CITI Program for NIH

NIH Secure Remote Computing

Center for Cancer Research (CCR) Clinical Trial Orientation

CCR Monitoring and Auditing in Clinical Trials

CCR Clinical Data Management

CCR Documentation and Document Management

CCR Protocol Development, Review and Approval

CCR Adverse Events

CCR Informed Consent

CCR Responsibilities of the Research Team

CCR Clinical Trial Design

CCR Overview of Good Clinical Practice and Human Subjects Protection

CCR Drug Development: Role of the FDA and Sponsor

NIH Office of Clinical Research Training:

Introduction to the Principles and Practice of Clinical Research

Principles of Clinical Pharmacology

NIH Clinical Center, Office of Research Support and Compliance (ORSC) Training:

Principles of Good Documentation

Risk Management in Pharmaceutical Manufacturing

Corrective and Preventative Actions

Management Responsibility for Quality: What FDA Expects

FDA Training and Qualification Requirements

Understanding GMPs for Facilities and Equipment

Principles of Aseptic Processing

Orientation to GMP Compliance

Meeting GMP Training Requirements

Environmental Control and Monitoring

Introduction to Data Integrity

Data Integrity for Quality Control Laboratories

Introduction to GMPs

Maintenance and Cleaning of Drug Manufacturing Equipment

Writing and Reviewing SOPs

Batch Record Reviews

Documenting Validation Activities

Failure Investigations for Pharmaceutical Manufacturers

GMP Principles for Batch Records

Gowning for Sterile Manufacturing

ICH Q7: Introduction and Quality Management

ICH Q7: Resources and Materials Management

Change Control

Care and Handling of Drug Product Components, Labeling, Containers, and Closures

How to Meet Drug Retention and Stability Testing Requirements

Complaint Management for Pharmaceutical Manufacturers

Biotechnology: An Overview of Compliance Considerations

Applications of GMPs to Microbiology Laboratories

Pharmaceutical and Medical Device Supplier Quality Management

GMP Updates: Supply Chain Quality and Emerging Compliance Concerns

NIH Office of Research Facilities, Division of Technical Resources (DTR) Training:

cGMP Modules 1 & 2 – Critical Aseptic Processing Facility (APF) Design Elements

cGMP Module 3 – Commissioning, Qualification and Validation (CQV) of APF

cGMP Module 4 – Program Management Process (PMP) for APF

NIH Administrative Training:

NIH Core Curriculum Training Parts 1 – Initiative Development Phase; 2 – Application Submission, Receipt and Referral; 3 – Scientific Review Group Meetings; 4 – Peri-Council Activities; and 5 – Post-Award Monitoring and Closeout

Receipt and Referral 101 Schedule Training

DoD Annual Training:

Annual DoD Cyber Awareness Challenge Training and Exam

U.S. Army Threat Awareness and Reporting Program (TARP) Training and Exam

Audit Awareness Training

Annual Security Refresher Training DCS Session

NIH Annual Training:

Annual NIH Information Security and Management Refresher: Information Security, Counterintelligence and Insider Threat, Privacy Awareness, Records Management, and Emergency Preparedness

Annual NIH Ethics Training

Annual NIH Harassment Doesn’t Work Here Training

NIH Implicit Bias Training

NIH Training in Tact & Diplomacy

Professional Qualifications:

My areas of expertise include program management, operations management, clinical trials, regulatory affairs management, quality assurance, Contract Research Organization (CRO) management, Contracts, GMP manufacturing, CMC, regulatory agency submissions (global), business portfolio management, strategic business initiatives, formulation development, risk assessments and management, medical countermeasures, vaccines, antibody therapeutics, monoclonal antibodies, nanobodies, biopharmaceutical conjugates, small molecule anti-viral drugs, research and development, small business management, nanotechnology, molecular biology, biochemistry, biophysics, genetics, cell biology, cancer therapeutics, gene and cell therapies, nanomedicine, targeted delivery, gene expression, genetic recombination, high-throughput screening, design thinking, software development, novel digital solutions, and others. I have extensive administrative experience with contracts, procurement, finance, legal review for large pharmaceutical companies, meeting scheduling and agendas, generating extensive meeting minutes, moderating meetings, group task tracking and subsequent follow up. I also specialize in the review of DoD and NIH applications for competitive funding, scientific data, manuscripts for publication, and Food and Drug Administration (FDA) submissions. My expertise also includes writing proposals and scientific manuscripts, grant applications and GMP documentation. I have extensive editorial expertise in scientific manuscripts, books, GMP and FDA documentation and submissions. I am qualified to mentor and train students at all levels, junior and senior scientists in academics and pharmaceutical companies, and clinicians.

Experience:

Independent Contractor/Consultant 11/2024 – present

Location: Remote

Saratoga Medical Center Inc: Scientific Subject Matter Expert (SME) for NIH PSTSS Solicitation to provide scientific and professional expertise to support NIAID’s current and emerging research priorities. Support includes specialized scientific expertise related to basic, translational and clinical research; vaccine research and development; general laboratory research at BSL-2, -3, and -4; veterinary and scientific research in ABSL-2, -3 and -4 environments; and bioinformatics and computational biology.

Global regulatory affairs and strategy services for pharmaceutical products including therapeutic biologics, large and small molecules, devices (medtech), consumables, and others

Tata Consultancy Services (TCS), Senior Business Consultant 3/2023 – 11/2024

Location: Remote and Business Travel to Client Sites

My current role is identification, development and expansion of business opportunities for TCS, a global IT company. I work to bridge the fields of IT, Biopharmaceuticals, and Regulatory Affairs and Strategies to provide clients with optimized digital solutions. I provide Domain expertise for large molecules, manufacturing, design, and CMC including applications for vaccines, monoclonal antibodies (mAbs) and nanobodies and their conjugates, cell therapies, gene therapies, recombinant proteins, synthetic peptides, and oligonucleotides (e.g., siRNA, saRNA). I also contribute to all TCS Pharma Business Teams on these topics and assist with Request for Proposal (RFP) and Request for Information (RFI) submissions (e.g., AstraZeneca, GSK, Roche, Bayer, Lilly, J&J, Kenvue, Cytiva/GE, Amgen, Pfizer, PPD/Thermo Fisher). To these TCS Pharma Teams, I have provided roadmaps for Cell and Gene Therapies (CGT) both for novel, optimized biotherapeutics and optimized digital solutions. I provided CMC and regulatory affairs services for pharmaceutical products including therapeutic biologics, large and small molecules, devices (medtech), consumables, and others. I have also provided presentations and meetings to train TCS associates on Domain topics including vaccines, biotechnology products and technologies, mAbs, nanobodies, conjugates, high-throughput screening, targeted delivery, CGT, and others. I have also thoroughly reviewed all products and services for the Pharmaceutical Companies listed above, created spreadsheets, shared these documents and made presentations covering these materials to TCS associates.

I have successfully completed numerous TCS courses over all disciplines including Technology, Domain, Process, Functional, and Leadership Business Skills. I received the highest badge for learning, the Guru Badge. I was also the 2nd top Star Learner on the 2024 TCS North America Leadership Board. I have earned hundreds of TCS Competencies and Certifications (see separate documents for specific listings). Notably, I have achieved advanced Competencies in Digital Design Thinking and Generative Artificial Intelligence (AI). I also assist and mentor other Team members and am a registered Mentor in TCS iConnect. I have been trained in and have a working knowledge of ELN, LIMS, SDMS, and CDS.

Oxford Global Resources, Senior Project Manager and Operations Manager 6/2022 – 2/2023

Supporting Takeda Global Research Strategy and Operations, Drug Discovery Sciences, Takeda Pharmaceuticals International Co.

Location: Remote

This position covers all scientific and administrative support for a new Takeda program to produce novel siRNAs, oligonucleotide-antibody conjugates, therapeutics, and strategies. I coordinate and perform all duties among scientific and administrative groups located globally. Specific duties include and are not limited to developing and updating work plans, maintaining project timelines and financial affairs, CRO and consultant contract review and submissions, CRO Management, invoice review and authorizing payments, overall budget maintenance, all SAP and Ariba tasks, meeting Takeda Ventures expectations and requirements, meeting Takeda Ethics & Compliance regulations, interfacing with Takeda Legal Services and Procurement (Takeda Business Solutions) to award and maintain contracts and consulting agreements, conducting scientific meetings and follow up with all CRO Teams and consultants, creating meeting minutes and agendas, tracking group tasks with subsequent follow up, providing scientific review and advice on the Project, interacting with all Takeda Stakeholders, ensuring portfolio management and effectiveness, effective system utilization, accurate data aggregation, valuable reporting, documentation maintenance and distribution, compliance with PM Community of Practice and PM Best Practices, ensuring project success, lead project workstreams and initiatives, resolving issues, creation of mitigation plans, development of trusted partnerships with global project managers, effective dissemination of key information, provide updates for project activities, provide project goals and strategies, root cause assessment, support of the broader Takeda organization, and others.

eTeam Inc., Senior Project Manager and Operations Manager 5/2021 – 5/2022

Supporting Takeda Genesis Labs, Takeda Pharmaceuticals International Co.

Location: Remote

This position covers all scientific and administrative support for a new Takeda program to achieve immune tolerance required for specific Gene and Cell Therapies, and Drug Development. I coordinate and perform all duties among scientific and administrative groups located globally including the US (Cambridge MA, San Diego CA, others), Tokyo Japan, the United Kingdom, Germany, and France. Specific duties include and are not limited to developing and updating work plans, maintaining project timelines and financial affairs, CRO and consultant contract review and submissions, CRO Management, invoice review and authorizing payments, overall budget maintenance, all SAP and Ariba tasks, meeting Takeda Ventures expectations and requirements, meeting Takeda Ethics & Compliance regulations, interfacing with Takeda Legal Services and Procurement (Takeda Business Solutions) to award and maintain contracts and consulting agreements, conducting scientific meetings and follow up with all CRO Teams and consultants, creating meeting minutes and agendas, tracking group tasks with subsequent follow up, providing scientific review and advice on the Project, interacting with all Takeda Stakeholders, ensuring portfolio management and effectiveness, effective system utilization, accurate data aggregation, valuable reporting, documentation maintenance and distribution, compliance with PM Community of Practice and PM Best Practices, ensuring project success, lead project workstreams and initiatives, resolving issues, creation of mitigation plans, development of trusted partnerships with global project managers, effective dissemination of key information, provide updates for project activities, provide project goals and strategies, root cause assessment, support of the broader Takeda organization, and others.

Astrix Technology Group, Regulatory/Quality Specialist (CCR), 12/2019 – 5/2021

Study Agent Management Director (CCR),

Senior Scientific Program Manager (Astrix),

and Scientific Researcher (Astrix)

Supporting the Office of Sponsor and Regulatory Oversight, National Cancer Institute (NCI), NIH

Location: Frederick, MD

This position covers all Regulatory and Quality Assurance work required for Center for Cancer

Research (CCR)-sponsored NCI clinical trials, with an emphasis on Quality Information, CMC Management, and risk assessments and management. These trials cover therapeutics and vaccines to treat cancer and to prevent HIV infection. I provide strategic guidance for CMC regulatory filings for FDA submissions, coordinate these filings, review sections, and provide recommendations for additional content, and liaison with the Food and Drug Administration (FDA). In addition, I review and revise Quality Agreements among all Stakeholders, Clinical Trial proposals, Investigator Brochures, SOPs, Procedure Forms, device submissions to the FDA, and others. Additional duties include performing risk assessments and management, participation in critical teleconferences addressing paths forward for certain Clinical trials and CMC issues, provide recommendations for paths forward, and others. I assist in providing for clinical trials sponsor and regulatory management support services to the National Cancer Institute (NCI), the Center for Cancer Research (CCR), and CCR investigators. Services include compliance with U.S. and international regulations, regulatory support to ensure FDA regulation adherence, safety monitoring, oversight and reporting, clinical site assessment and interim monitoring, site essential regulatory documentation, trial master file support, sponsor quality management support, medical writing, administrative support, and computerized activity tracking, monitoring, and reporting systems. I also assist in supporting management of multi-center trials in which the CCR is the Sponsor, and in non-CCR sites recruitment and management.

Logistics Management Institute, Senior Regulatory Affairs Manager 09/2018 – 11/2019

and Senior Consultant

Supporting DTRA JSTO-CB (Joint Science & Technology) and JPEO-CBRND (Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense) and

One Regulatory Network for Excellence, Regulatory Affairs Quality Assurance (ONE-RAQA)

PRISM/ADAMANT/MCS/ONE-RAQA, Anti-BoNT A/B and Rapid Response and Enabling Biotechnology (EB) Projects

Location: Frederick, MD

These projects focus on the production of effective monoclonal antibodies (mAbs) to rapidly treat humans infected by botulinum toxin (Anti-BoNT A/B), pneumonic plague, and other known or unknown bioterrorism targets (Rapid Response). Enabling Biotechnology Projects include those involving SAB Therapeutics, Sunflower Therapeutics Programs, and Ology Biosciences. I serve as the Subject Matter Expert (SME) and Senior Regulatory Affairs Manager for Anti-BoNT A/B, Anti-Plague, and Rapid Response and Enabling Technology Programs. In addition, I serve as the SME and Regulatory Affairs Manager to ONE-RAQA (JPEO) to provide further regulatory oversight for these programs, particularly regarding all FDA, OTA and SOW submissions, and presentations to the FDA. ONE-RAQA support also includes writing Risk Assessment Reports and other reports, providing written updates in table formats, and providing Position Papers and Program recommendations. I attend all meetings, review technical and regulatory documents, assist in the design of animal experiments and clinical trials, manage quality assurance, perform extensive subject matter searches, and provide further consultation upon request. I also serve on expert panels for PRISM/ADAMANT annual Program Reviews, and on the SSEB review board for OTAs and SOWs. I develop Regulatory Strategies and Target Product Profiles for all projects. I routinely facilitate required networking among different DoD functional groups, and between DoD contractors and the appropriate DoD POCs to accomplish Program goals. The tools and methods used are those employed by the FDA Regulatory Guidance and ONE-RAQA. Techniques involve providing support and guidance, teaching, use of Internet search engines, and mediation when needed to resolve divergent agendas. My work results in benefit and value to the client by providing critical evaluation, oversight and review to achieve the projects’ end goals in the most efficient and expedient pathways forward. My work also ensures the highest protection to the DoD’s investments, safety to human subjects involved in clinical trials, and product safety and efficacy for FDA approvals.

Additional responsibilities include the following: Serve as the designated senior regulatory, quality assurance and environmental and safety expert to the JPEO. Oversee the planning, scheduling and coordinating of regulatory submissions assigned to ensure their quality, consistency, completeness and adherence to content and format standards. Assist in Investigational New Drug (IND) / New Drug Application (NDA)/ Biologics License Application (BLA) / Pre-Market submission 510(k) regulatory strategy, development and maintenance. Ensures that non-clinical, chemistry, manufacturing and controls (CMC), clinical and product labeling information meet applicable regulatory requirements. Perform technical/scientific/regulatory reviews of clinical protocols, informed consents and other clinical trial documents. Review of human subjects research by the U.S. Army Surgeon General's Human Subjects Research Review Board. Perform technical/scientific/regulatory reviews of all non-clinical protocols, reports and other documents. Ensure and coordinate the review of all animal research studies by the U.S. Army Medical Research & Materiel Command (USAMRMC) Animal Care and Use Research Office. Perform technical/scientific/regulatory reviews of chemistry, manufacturing and controls (CMC) documents. Support internal Government Integrated Product Teams (IPT) activities and assume responsibility for regulatory activities, as necessary, to fulfill JPEO needs. Assist in the revision and publication of DoD/DA policies and regulations. Provide interpretation of various DA/DoD, FDA and other regulations and policies. Participate in FDA meetings and other Government IPT meetings. Participate in FDA inspection debriefings of DoD contractor facilities. Perform regulatory intelligence and keep JPEO aware of new and evolving FDA, DA, And DoD regulations, policies and guidelines. Provide JPEO quality oversight in support of the product management offices, including conducting quality audits, document reviews, evaluation of GxP compliance and quality system documentation, and training. Coordinate with the Product Managers and Deputy Product Managers and item managers to determine critical points of oversight required to develop chemical, biological and radiological medical countermeasures and diagnostics. Ensure conformance with all FDA regulations appropriate for the level of product development. Interface with contractor personnel in Development, Manufacturing, QA and RA to ensure that objectives and activities align with all FDA regulations appropriate for the level of product development. Oversee and ensure appropriate JPEO preparation, management and response to FDA regulatory inspections of contract manufacturing facilities. Ensure the appropriate QA involvement in the evaluation of the impact of quality issues, regulatory inspections and cases of potential fraud and misconduct. Ensures compliance with DoD/DA policies and regulations regarding environmental analysis of Army actions (NEPA) and biosafety.

BDTX/JPEO/ONE-RAQA, Remdesivir (GS-5734) Program and Anti-Viral Therapeutics

These projects focus on the production of effective anti-viral therapeutics to treat humans infected by viruses including filovirus (e.g., Ebola, Marburg, and Sudan viruses), Venezuelan Equine Encephalitis Virus and alphaviruses. I serve as the SME and Senior Regulatory Affairs Manager for the Remdesivir and all other Anti-Viral projects. In addition, I serve as the SME and Regulatory Affairs Manager to ONE-RAQA (JPEO) to provide further regulatory oversight for the Remdesivir and Anti-Viral projects, particularly regarding all FDA, OTA and SOW submissions, and presentations to the FDA. ONE-RAQA support also includes writing all reports, providing written updates in table formats, and providing Position Papers and Program recommendations. I attend all meetings, review technical and regulatory documents, assist in the design of animal experiments and clinical trials, manage quality assurance, perform extensive subject matter searches, and provide further consultation upon request. I also assist in preparations for Milestone Pre-Briefings and associated meetings, e.g., Milestone B. I review potential early-stage anti-viral projects from various sources (e.g., DTRA, academic, pharmaceutical companies) for inclusion in advanced MCS programs. I develop Regulatory Strategies and Target Product Profiles for all projects. I routinely facilitate required networking among different DoD functional groups, and between DoD contractors and the appropriate DoD POCs in order to accomplish Program goals. The tools and methods used are those employed by the FDA Regulatory Guidance and ONE-RAQA. Techniques involve providing support and guidance, teaching, use of Internet search engines, and mediation when needed to resolve divergent agendas. My work results in benefit and value to the client by providing critical evaluation, oversight and review to achieve the projects’ end goals in the most efficient and expedient pathways forward. My work also ensures the highest protection to the DoD’s investments, safety to human subjects involved in clinical trials, and product safety and efficacy for FDA approvals.

DTRA/ONE-RAQA, OTA and SOW Reviews

These DTRA OTA and SOW submissions focus on DoD interests in the Med Chem Defense area. I serve as the SME and Regulatory Affairs Manager to ONE-RAQA (JPEO) to provide both Technical and Regulatory perspectives, assessment of the technologies’ developmental phase, determination of the required pre-IND enabling studies, elucidating the steps necessary for the next level of FDA engagements, and provide scientific and technical advice for FDA division regulatory review or for drug development. I serve on expert panels for review of these DTRA proposals. The tools and methods used are those employed by the FDA Regulatory Guidance and ONE-RAQA. Techniques involve providing support and guidance, teaching, and use of Internet search engines. My work results in benefit and value to the client by providing critical evaluation and review to assist in selecting the most promising proposals to achieve DoD’s mission. My work also ensures the highest protection to the DoD’s investments and proposed Regulatory pathways.

JVAP/MCS/ONE-RAQA, Recombinant Botulinum Vaccine A/B (rBV A/B), and Advanced Development of rF1V as a Plague Vaccine

These projects focus on the production of effective prophylactic vaccines to protect humans against infection by botulinum toxin (BOT) or plague. I serve as the SME and Senior Regulatory Affairs Manager for BOT and as a backup for the Plague SME to support MCS. In addition, I serve as the SME and Regulatory Affairs Manager to ONE-RAQA (JPEO) to

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